First Patients are Vaccinated in IMPRINT*, immatics’ Pivotal Phase III Trial With IMA901 in Patients With Renal Cell Carcinoma (RCC)

By Immatics, PRNE
Tuesday, June 14, 2011

TUEBINGEN, Germany, June 15, 2011 -

igoommatics biotechnologies GmbH, a biopharmaceutical
company developing advanced therapeutic vaccines that are active
against cancer, announced today that the first patients have been
vaccinated in the IMPRINT study, a pivotal Phase III trial with
IMA901, the company’s lead cancer vaccine for the treatment of
renal cell carcinoma (RCC).

The trial is designed to demonstrate the overall survival
benefit of IMA901 in combination with standard first-line therapy
in RCC patients. The study builds on the promising survival and
immune response data observed in the Phase II study with IMA901 in
advanced RCC patients. Data from the Phase II study were presented
at ASCO in June 2010 and at ESMO in October 2010.

IMPRINT is a global multicenter, randomized, controlled Phase
III study in patients with metastatic and/or locally advanced RCC
who are candidates for receiving standard first-line therapy with
sunitinib (Sutent®,Pfizer). The trial will include approximately
330 patients across the US and Europe.

The primary endpoint of the Phase III study is overall survival
in patients receiving IMA901 in combination with sunitinib versus
sunitinib alone. Overall survival will also be tested in patients
who are positive for a prospectively defined biomarker signature.
This signature was identified as being predictive for improved
clinical outcome in IMA901-vaccinated patients in the previous
Phase II study. Details on the biomarker signature were presented
in the plenary session of the Annual Meeting of Association for
Cancer Immunotherapy (CIMT) in late May 2011.

Further secondary endpoints include progression-free survival,
safety and tolerability, and cellular immunomonitoring to assess
the T-cell response to the peptides contained in IMA901. Data from
the reported Phase II trial showed that the intensity of the immune
response against the IMA901 TUMAPS vaccine was predictive for
improved overall survival.

The first overall survival results of the study are expected in
late 2013. The chief investigator of the trial is Professor Brian
, Associate Director for Clinical Research at the Cleveland
Clinic Taussig Cancer Institute, Cleveland, Ohio and Professor Tim
, Clinical Director of Medical Oncology at Addenbrooke´s
Hospital, University of Cambridge, UK, is the European lead

Carsten Reinhardt, CMO of immatics, said: “The
start of this Phase III trial with IMA901 is a key milestone in
immatics clinical development. The protocol for this
trial builds on the encouraging insights gained from the Phase II
study and feedback from key opinion leaders as well as successful
meetings with regulatory agencies both in Europe and the US. We
look forward to confirming the positive overall survival data seen
in the phase II study as advanced renal cell cancer still has a
very high unmet medical need.”

Paul Higham, CEO of immatics, added: “An overall
survival benefit combined with a stable and easy to manufacture
formulation would make IMA901 an important breakthrough in the
development of therapeutic cancer vaccines.”

*IMPRINT = IMA901 Multi-Peptide vaccine
Randomized INTernational study

About IMA901

IMA901 is a rationally designed cancer vaccine comprising 10
different tumor-associated peptides (TUMAPs) that are found to be
highly over-expressed in the majority of patients suffering from
RCC. IMA901 is a peptide-based vaccine with a stable, off-the-shelf
formulation and robust and easily scalable manufacturing.

About immatics

immatics biotechnologies is a clinical-stage
biopharmaceutical company developing advanced therapeutic vaccines
that are active against cancer. immatics lead
product, IMA901, is in a pivotal Phase III study after completing a
successful Phase II trial in renal cell carcinoma.
immaticspipeline also includes IMA910, in Phase II
for colorectal cancer, and IMA950, which is being developed for

immaticstechnology platform rapidly generates
defined therapeutic cancer vaccines which are based on multiple
tumor-associated peptides (TUMAPs) with the ability to specifically
stimulate the immune system against cancer cells. These vaccines -
comprising multiple peptides confirmed to be naturally presented by
real tumor tissue - offer the prospect of greater effectiveness
than existing cancer vaccine approaches combined with fewer side
effects. immaticsproducts are ‘drug like’ with
stable, off-the-shelf formulations and robust easily scalable

immatics is based in Tuebingen and Munich, Germany,
immatics is based in Tuebingen and Munich, Germany, and has
raised €108 million (US$158 million) in private equity in three
financing rounds to date, with the last €54 million completed in
September 2010.

For additional information on immatics please visit href=""> or

Paul Higham, CEO
Katrin Eckert, Assistant to the Management
immatics biotechnologies GmbH
Phone: +49-7071-5397-110
E-mail: href="">

Citigate Dewe Rogerson
David Dible / Chris Gardner / Sita Shah
Phone: +44-207-638-9571


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